RFC and MTHFR SNPs & hENT1- dCK Expression as Prognostic Factors in ALL & hENT1- dCK Expression as Prognostic Factors in AML

Evaluation of RFC Transporter & MTHFR SNP's, as Well as hEN1 and DCK Expression as Prognostic Factors in Patients With Acute Lymphoblastic Leukemia.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01307241

Enrollment

Registered

2011-03-02

Start date

2010-12-31

Completion date

2015-12-31

Last updated

2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia., Acute Myeloblastic Leukemia

Keywords

Acute lymphoblastic leukemia, prognostic factor, pharmacogenetics.

Brief summary

Results of actual treatment in ALL are not optimal. New prognostic factors, which may determine clinical & molecular response are required. Hyper-CVAD is an internationally accepted schema for such patients. The objective of this pilot study is to evaluate polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the function of these proteins, and therefore the intracellular bioavailability of methotrexate. Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for citarabine intracellular transport and activation, respectively. Clinical characteristics will be tabulated and analyzed for responders & non-responders patients. Uni- & multivariate analysis will be done to evaluate factors influencing on response and survival.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age: older than 15 years. * Male, female. * Normal renal & liver functions. * Without previous treatment. * Candidate to be treated with hyperCVAD Schema (ALL patients). * Candidate to receive induction remission with cytarabine (AML patients)

Exclusion criteria

* Patients not candidate to receive methotrexate or cytarabine.

Design outcomes

Primary

Measure	Time frame	Description
Clinical responses in relation with SNP's or gene expression	clinical response.	—
To evaluate clinical response	December 2012	To evaluate clinical response after ending Hyper-CVAD schema for ALL patients. To evaluate clinical response & DFS in relation with hENT1 & dCK expression levels in AML patients.

Countries

Mexico

Outcome results